Secondary Primary Tumor Prevention With EGFR, OSI-774, and Cyclooxygenase-2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dong Shin, Emory University
ClinicalTrials.gov Identifier:
NCT00400374
First received: November 15, 2006
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

This is a phase I/II study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).


Condition Intervention Phase
Head and Neck Cancer
Drug: Erlotinib, Celecoxib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I/II Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcinoma of Head and Neck

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Define biologic dose of Erlotinib and Celecoxib in Erlotinib plus Celecoxib in patients with early stage (I/II) SCCHN. Improve overall survival rate by reducing SPTs and recurrence with combination of Erlotinib and Celecoxib. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess tolerability and toxicity associated with combination of Erlotinib and toxicity associated with combination of Erlotinib and Celecoxib for patients with early stage (I/II) SCCN. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 82
Study Start Date: August 2007
Estimated Study Completion Date: November 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Erlotinib, Celecoxib
Erlotinib self-administered 100 mg daily 30 days for 6 months. Celecoxib 400 mg, 30 days for 6 months.
Other Name: OSI-774, Cyclooxygenase-2
Drug: Erlotinib, Celecoxib
Erlotinib, 100 mg, daily for six months. Celecoxib, 400 mg, daily for six months.

Detailed Description:

This is a phase I/II study of second primary tumor prevention in early stage (stage I/II) patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).

The study will evaluate the effect on cells and clinical response to study medications: Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the medications will be assessed, and chemicals in the cells will be evaluated both before and after medication is administered that may show how the drugs work. This information will help researchers determine whether additional studies with these drugs should be conducted to determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.

SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new cases in the United States per year with 11,000 deaths. The five-year survival rate for patients with SCCHN in the United States and other developed countries is still poor, approximately 40%, comparable to the five-year survival rate in the 1970s despite advances in detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before the development of invasive cancer or second primary tumors (SPTs) is highly desirable and novel strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related malignancies are being pursued.

Approximately 82 patients will participate at the Emory Winship Cancer Institute, Emory Crawford Long Hospital, and Grady Memorial Hospital in Atlanta, Georgia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have, or have previously had, stage I (T1NO) or stage II (T2NO) squamous cell carcinoma of the head and neck.
  • Tumor sites include oral cavity (buccal mucosal, gingival, floor of mouth, dorsal/ventral tongue, pharyngeal wall), oropharynx, larynx (glottis, supraglottis, subglottis, epiglottis) hypopharynx, paranasal sinus and nasal cavity.
  • May have oral pre-malignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ) provided their Stage I or II disease has been definitively treated.
  • Must have been free of disease for a minimum period of 8 weeks up to maximum of 3 years following completion of surgery and/or radiotherapy.
  • Must have an ECOG/Zubrod performance status of 0-1.
  • Patients must be 18 years of age or greater.
  • Female patients of childbearing potential must practice adequate contraception and have a negative pregnancy test (β-HCG).
  • Must be able to swallow the Erlotinib and Celecoxib pills.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

  • Acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
  • History of previous malignancies other than squamous cell carcinoma of the head and neck unless the cancer was non-melanoma skin cancer.
  • Participants who are pregnant or breast feeding.
  • Documented history of coagulopathy and/or those taking warfarin or warfarin-derivative anticoagulants within 6 months of entry into the study.
  • Hypertension not adequately controlled by medication as shown by a systolic ≥180 @ screening.
  • Documented history of interstitial lung disease.
  • Known connective tissue disease.
  • Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
  • Any active cardiovascular events including angina, unstable angina, palpitation, tachycardia, arrhythmia, or participant has had a recent CVA (stroke) or Myocardial Infarction (< 6 months).
  • Any history of clinically significant ventricular arrythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400374

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Dong Shin, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Dong Shin, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00400374     History of Changes
Other Study ID Numbers: 0405-2006
Study First Received: November 15, 2006
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Head and Neck Cancer

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Celecoxib
Cyclooxygenase 2 Inhibitors
Erlotinib
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014